Sulforaphane Supplementation in Atopic Asthmatics

NCT ID: NCT01845493

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-10-31

Brief Summary

The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN) for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is possible with this supplementation regimen in individuals with allergic asthma.

Detailed Description

This pilot study will examine if oral SFN supplementation can induce NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells of allergic asthmatics. Subjects will receive both a SFN-rich broccosprout homogenate preparation and an alfalfa sprout homogenate (placebo) in a crossover fashion. mRNA levels of NRF2 and NRF2-dependent phase II enzymes will be compared between the active and placebo periods.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sulforaphane-rich supplement

Intervention: broccosprout homogenate (rich in Sulforaphane) taken orally daily x 3 days

Group Type: ACTIVE_COMPARATOR

Sulforaphane Homogenate

Intervention Type: DIETARY_SUPPLEMENT

Active

Alfalfa Sprout Homogenate

Placebo: Alfalfa sprout homogenate taken daily x 3 days (poor in sulforaphane)

Group Type: PLACEBO_COMPARATOR

Alpha Sprout Homogenate

Intervention Type: DIETARY_SUPPLEMENT

Alpha Sprout Homogenate

Interventions

Alpha Sprout Homogenate

Alpha Sprout Homogenate

Intervention Type: DIETARY_SUPPLEMENT

Sulforaphane Homogenate

Active

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

1. Age 18-50 of both genders

2. History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years.

3. AND: Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine). Methacholine challenge in a separate screening protocol (98-0799), or from other venues will be accepted.

4. OR: Pre and post bronchodilator FEV1 improvement by 12% or more after 4 puffs of albuterol inhaler.

5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma (NHANES III predicted set).

6. Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response in a separate screening protocol. Proof of allergy from other venues, including ImmunoCAP testing from a medical workup, provided by the subject, will be accepted.

7. Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg)

8. Willing to provide information regarding health history and habits of cigarette smoke exposure;

9. Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with added vitamin supplements for 2 days prior the baseline screening visit and throughout initial dosing period.

10. Subjects must be willing to avoid antihistamine use for 4 days prior to each session and NSAIDs for 7 days prior to each session. Nasal steroids must be held for 2 weeks prior to the session.

Exclusion Criteria

1. Medical history or underlying health problems that preclude participation in the protocol per the study physician;

2. Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;

3. Use of oral corticosteroids within the past 4 weeks;

4. Presence of upper or lower respiratory tract infection or treatment with antibiotics within the previous 4 weeks;

5. Pregnancy as determined by menstrual history or urine pregnancy test;

6. Current smokers will be excluded. Anyone with a smoking history > 0.5 pack year and/or >1 pack per month will also be excluded.

7. History of bleeding disorder;

8. Recent nasal surgery (with 6 months). If a subject has had nasal surgery between 6 months and 5 years, a study physician will visualize the area prior to the biopsy to evaluate the suitability of the nose for the procedure.

9. History of intolerance of or aversion to broccoli

10. Unable to withhold nasal steroids for 2 weeks before each session. These subjects may be deferred until after their allergy season.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Michelle Hernandez, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle L Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

center for environmental medicine asthma and lung biology

Locations

Environmental Protection Agency at the University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

13-0056

Identifier Type: -

Identifier Source: org_study_id